NCT00399451Unknown1 期
Preliminary Study on Submucous Sclerosis of Pharynges With 1% Polidocanol to Treat Obstructive Sleep Apnea (OSA) & Snoring Subjects (SS)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 主要终点
- apnea-hypopnea index (AHI)is on polysomnography(PSG),to compare AHIanterior and posterior treatment.
研究概览
简要总结
The aim of this prospective study is to evaluate the results of polidocanol sclerotherapy of pharynx for OSAS & SS,to reduce pharyngeal compliance.
详细描述
Polidocanol submucous sclerosis in the part of pharynges with 1% polidocanol injection.The injection should be in the retropharyngeal submucosa and lateral pharyngeal bands and lateral pharyngeal submucosa and in front submucosa of soft palate.The injection is multi-point,and each point injection is 0.3~0.5ml;the total quantity/each time is not more than 5ml.Every patient have to be treated about 1~2 time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OSAS & SS which palatopharyngeal collapse.
排除标准
- •obstructive sleep apnea syndrome (osas) & snoring subjects (ss),which anatomic narrow result in.
结局指标
主要结局
apnea-hypopnea index (AHI)is on polysomnography(PSG),to compare AHIanterior and posterior treatment.
次要结局
- Arterial oxygen saturation (SaO2) and body mass index (BMI)will be measured on polysomnography
研究者
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